Catalog Number

R57525-00-E2

Brand Name

Rocket

Version/Model Number

R57525-00-E2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K032015,K032015,K032015

Product Code

-

Product Code Name

-

Public Device Record Key

6b34680c-e04c-4505-9738-e681647e1bb1

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 07, 2016

Package DI Number

05055270966094

Quantity per Package

10

Contains DI Package

05055270966087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-